Bionxt sends cladribine API to CDMO partner

Mr. Hugh Rogers reports BIONXT REPORTS SUBLINGUAL CLADRIBINE MULTIPLE SCLEROSIS DRUG MILESTONES INCLUDING LARGE-ANIMAL STUDY FOR VALIDATION AND DOSING OPTIMIZATION Bionxt Solutions Inc. has provided an update on its proprietary cladribine sublingual thin-film drug reformulation program (BNT23001), a next-generation delivery platform designed to improve bioavailability, patient adherence and therapeutic outcomes in the treatment of neurological disorders, primarily multiple sclerosis (MS). Cladribine sublingual thin-film program: manufacturing and development milestones Bionxt has successfully completed key technology transfers to its European contract development and manufacturing organization (CDMO), including both the process transfer and the analytical method transfer. These achievements represent critical steps toward ensuring reproducibility, scalability and regulatory compliance in the production of the company's pharmaceutical-grade sublingual thin-film dosage forms. In parallel, Bionxt confirms that the active pharmaceutical ingredient (API) for cladribine has been ordered and is currently in transit to the CDMO for use in the manufacturing of a pilot batch. This batch will be used to produce clinical-grade thin-film products, advancing the program toward its next preclinical and clinical phases. The company is now preparing for the optimization and validation of analytical methods, together with the final refinement of product and process parameters at its CDMO partner. These activities will enable the production of sublingual thin-film samples for a large-animal (pig) bioavailability study, scheduled to begin in October, 2025. Pigs are widely recognized as a translationally relevant model for human gastrointestinal absorption, and this study is specifically designed to confirm and strengthen the highly promising bioavailability results demonstrated in earlier animal studies. A successful outcome will provide robust, clinically translatable evidence of the formulation's performance, establishing the final preclinical validation step and dosage optimization prior to human evaluation. Building on this foundation, Bionxt plans to manufacture a pilot batch for a first-in-human clinical pilot study, targeted for Q1 2026. This milestone trial would represent a major inflection point in the clinical development of Bionxt's cladribine sublingual reformulation. Clinical and market impact Bionxt's cladribine sublingual thin-film program, BNT23001, represents a novel approach to oral drug delivery in neurological disease, with the potential to improve patient outcomes through enhanced pharmacokinetics and ease of administration. The program also complements Bionxt's growing portfolio of proprietary sublingual thin-film technologies targeting high-value pharmaceutical markets. "With both our development program and global patent strategy advancing on schedule, Bionxt is steadily building the foundation for clinical translation and commercial success," said Hugh Rogers, chief executive officer of Bionxt. "Cladribine represents a powerful therapeutic option with untapped potential, and our sublingual thin-film reformulation may unlock significant advantages in terms of bioavailability, patient adherence and market accessibility. The progress we are reporting today reinforces our conviction in the program's importance as a core pillar of Bionxt's commercialization pipeline." Next steps: Completion of analytical optimization and validation at the European CDMO; Final process and product optimization, followed by clinical sample production; Initiation of a large-animal bioavailability study in October, 2025, expected to be the final preclinical study before human trials; Preparation for the manufacture of clinical samples for the first-in-human clinical study in Q1 2026; Continuing patent nationalizations and accelerated U.S. patent review under Track 1. About Bionxt Solutions Inc. Bionxt Solutions is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumours while reducing side effects. With research and development operations in North America and Europe, Bionxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. Bionxt is committed to improving health care by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide. Bionxt is listed on the Canadian Securities Exchange under the symbol BNXT and on the OTC (over the counter) market under the symbol BNXTF and trades in Germany under WKN: A3D1K3. We seek Safe Harbor.